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| ID | Type | Description | Link |
|---|---|---|---|
| B1811040 | Other Identifier | Alias Study Number |
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The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.
Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who have approved indications of Tygacil | Approved indications of Tygacil -complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tigecycline | Drug | As prescribed by physician in usual clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer. | From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. |
| Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications. | From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment | Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil . | At the TOC or EOT assessment |
Not provided
Inclusion Criteria:
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
Adults 18 years of age or older, who have one of the followings:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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General Hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | Gyeonggi-do | 443-380 | South Korea | ||
| Pusan National University Yangsan Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants were enrolled between May 2010 and April 2015 from Korean health care centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tygacil | Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site |
Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil . |
| At the TOC or EOT assessment |
| Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) | Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates. | At the TOC or EOT assessment |
| Yangsan |
| Gyeongsangnam-do |
| 626-770 |
| South Korea |
| Gachon University Gil Hospital | Namdong-gu | Incheon | 405-760 | South Korea |
| Wonkwang University Hospital | Iksan-si | Jeollabuk-do | 573-250 | South Korea |
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 561-712 | South Korea |
| Hanil Medical Center | Dobong-Gu | Seoul | 132-033 | South Korea |
| Kosin University Gospel Hospital | Busan | 602-702 | South Korea |
| Dong-A University Medical Center (Dong-A University Hospital) | Busan | 602-715 | South Korea |
| Cheongju St. Mary's Hospital | Cheongju-si | 363-568 | South Korea |
| Keimyung University Dongsan Medical Center (KUDMC) | Daegu | 700-712 | South Korea |
| Kyungpook National University Hospital (KNUH) | Daegu | 700-721 | South Korea |
| Daegu fatima hospital | Daegu | 701-724 | South Korea |
| Yeungnam University Medical Center | Daegu | 705-717 | South Korea |
| Daegu Catholic University Medical Center (DCUMC) | Daegu | 705-718 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 425-707 | South Korea |
| Ajou University Hospital | Gyeonggi-do | 443-721 | South Korea |
| Inha University Hospital | Incheon | 400-711 | South Korea |
| Gachon University Gil Hospital | Incheon | 405-760 | South Korea |
| Jeju National University Hospital | Jeju City | 690-767 | South Korea |
| Yonsei University Wonju College of Medicine- Wonju Christian Hospital | Kangwon-do | 220-701 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Yonsei University College of Medicine Severance Hospital Rheumatology Internal Medicine | Seoul | 120752 | South Korea |
| Kyunghee University Medical Hospital | Seoul | 130-702 | South Korea |
| Hallym University Kangdong Sacred Heart Hospital | Seoul | 134-701 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 134-727 | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | 134-814 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| Asan Medical Center, University of Ulsan | Seoul | 138-736 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Eulji Medical Center | Seoul | 139-711 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | 150-950 | South Korea |
| Hallym University Medical Center (HUMC) - Kangnam Sacred Heart Hospital | Seoul | 150-950 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Kangbuk Samsung Medical Center | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | 682-714 | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who received at least one dose of Tygacil and had related safety endpoints evaluated at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tygacil | Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Infection Site | cSSSI: Complicated skin and skin structure infection; cIAI: Complicated intra-abdominal infection; CAP: Community-acquired bacterial pneumonia. | Number | Participants |
| |||||||||||||||||||||||||
| Severity of Infection | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer. | Safety Analysis Set | Posted | Number | Percentage of Participants | From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment | Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil . | Effectiveness Analysis Set: Participants who received at least one dose of Tygacil and had related effectiveness endpoints evaluated at least. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At the TOC or EOT assessment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site | Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil . | Effectiveness Analysis Set. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At the TOC or EOT assessment |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications. | Safety Analysis Set. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) | Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates. | Effectiveness Analysis Set from the prospective study phase; n refers to the total nunber of participants who had evaluable data. | Posted | Number | Percentage of Participants | At the TOC or EOT assessment |
|
|
From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tygacil | Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. | 419 | 3,169 | 537 | 3,169 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of disease | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Mediastinitis | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Multiple organ failure | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Circulatory failure | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Brain hypoxia | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Brain stem disorder | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Carboxyhaemoglobinaemia | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Convulsions | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Oedema cerebral | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Clostridial infection | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Colitis pseudomembranous | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhagic | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Fibrillation atrial | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Fibrillation ventricular | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Bilirubinaemia | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hepatocellular damage | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Serum glutamic oxaloacetic transaminase increased | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Serum glutamic pyruvate transaminase increased | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Carcinoma small intestine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Leukaemia granulocytic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Melanoma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Coagulation disorder | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Haemorrhage not otherwise specified | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Chronic obstructive airways disease | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Stevens johnson syndrome | Skin and subcutaneous tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Renal failure chronic aggravated | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Renal function abnormal | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cerebral infarction | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Thrombophlebitis deep | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Leucopenia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Marrow depression | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Application site reaction | Injury, poisoning and procedural complications | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
| |
| Infection aggravated | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pyelonephritis | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | WHO-ART version 092 | Non-systematic Assessment |
| |
| Amputation | Surgical and medical procedures | WHO-ART version 092 | Non-systematic Assessment |
| |
| Secondary carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Surgical intervention | Surgical and medical procedures | WHO-ART version 092 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Serum glutamic oxaloacetic transaminase increased | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Serum glutamic pyruvate transaminase increased | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Phosphatase alkaline increased | Metabolism and nutrition disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 50 to 64 years |
|
| >=65 years |
|
| CAP |
|
| cIAI + cSSSI |
|
| cIAI + CAP |
|
| Severe |
|
| Title | Measurements |
|---|
|
| SADRs |
|
| Unexpected AEs |
|
| Unexpected ADRs |
|
|
|
|
|
|
|
|